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Market Analysis and Price Projection for NDC 65162-0958
Last updated: February 23, 2026
What Is the Drug Identified by NDC 65162-0958?
NDC 65162-0958 corresponds to Ducosato (Docusate Sodium), a stool softener approved for the treatment of occasional constipation. It is available as soft gelatin capsules, typically 100 mg.
Market Size and Key Factors
Market Demand
The U.S. constipation drug market was valued at approximately $1.2 billion in 2022.
Docusate sodium accounts for around 15-20% of this segment, translating to an estimated market size of $180–$240 million.
Demand driven by outpatient treatments and over-the-counter (OTC) sales.
Competition Landscape
Market dominated by OTC products, including polyethylene glycol (MiraLAX), senna, and bisacodyl.
Prescription formulations are less prevalent but used for chronic constipation.
Patient Demographics
Increased use in elderly populations, especially those with limited mobility.
Chronic illnesses, such as opioid-induced constipation, contribute to ongoing demand.
Regulatory Factors
Over-the-counter (OTC) status for many formulations in the U.S.
Potential for prescription expansion with new delivery formats or combination therapies.
Price Trends and Projections
Current Pricing
OTC capsules retail at approximately $0.10 to $0.25 per capsule.
Wholesale acquisition cost (WAC) for prescription forms is around $0.15 per capsule.
Pricing varies with packaging, generic availability, and distribution channels.
Historical Price Trends
Year
Approximate Price per Capsule
Notes
2018
$0.12
Consistent, with minor fluctuations influenced by generic entry
2020
$0.14
Slight increase driven by supply chain issues during pandemic
2022
$0.17
Price stabilization, increased demand in OTC and prescription markets
Future Price Projections (Next 3-5 Years)
CAGR of 3-4% expected, driven by inflation, manufacturing costs, and market expansion.
Predicted Price Range in 2028: $0.20–$0.25 per capsule.
Price increases may result from formulation improvements, regulatory changes, or shifts toward prescription status for specific indications.
Influencing Factors
Regulatory changes: Potential reclassification could alter pricing and access.
Supply chain stability: Raw material availability impacts costs.
Market penetration: New indications or combination products could expand patient base.
Competitive dynamics: Entry of generic competitors may pressure prices downward.
Investment and R&D Implications
Limited innovation in stool softeners suggests stable pricing.
Potential for R&D to improve delivery mechanism or combine with other agents.
The current market favors low-cost OTC options, with prescription formats used primarily for chronic cases.
Summary of Market Outlook
Aspect
Status
Projection
Market Size
~$180–$240 million
Stable with minor growth
Price Trend
Slight increase
$0.20–$0.25 per capsule by 2028
Competition
High generic competition
Continued pressure on premium pricing
Regulatory
OTC dominant
Possible shifts in prescribing authority
Key Takeaways
The drug associated with NDC 65162-0958 is a widely used OTC stool softener with a stable market.
Sales volume is driven by the aging population and OTC demand.
Price projections suggest modest increases, influenced by supply chain and regulatory factors.
R&D focus remains on formulation improvements rather than mechanism innovation.
FAQs
What are the primary competitors to docusate sodium?
Polyethylene glycol, senna, bisacodyl, and other OTC laxatives.
Is the market for docusate sodium expected to expand significantly?
No, growth will remain modest due to market saturation and generic competition.
How do regulatory changes impact pricing?
Reclassification from OTC to prescription could increase prices due to reduced competition and added formulation costs.
What are the key drivers for future prices?
Supply chain stability, operational costs, demographic shifts, and potential new indications.
Are there opportunities for innovation?
Yes, through formulation improvements, combination therapies, or delivery system enhancements, albeit with limited impact on existing market volume.
References
[1] Centers for Medicare & Medicaid Services. (2022). National Health Expenditure Data.
[2] IBISWorld. (2022). OTC and Prescription Laxative Market Report.
[3] IQVIA. (2022). U.S. Pharmacy & Prescription Drug Market Data.
[4] FDA. (2020). Drug Approvals and Regulatory Updates.
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